Qynapse (Paris) announced that it has landed FDA 510(k) clearance for its QyScore novel imaging software for central nervous system diseases.
QyScore enables automated quantification of a broad portfolio of magnetic resonance imaging (MRI) markers that are important in early diagnosis and clinical monitoring of neurodegenerative disorders such as Alzheimer’s and Parkinson’s diseases and multiple sclerosis, according to the company.
The software combines a user interface with patient reports and compares the results to a healthy subjects database. It is compatible with the clinical routine workflow to support differential diagnosis and the measure of clinical progression. It is also designed to quantify longitudinal changes in regions of interest in the brain, eliminating the inter- and intra-rater variability in images reading, and reducing the time and cost of image analysis.
“QyScore makes a difference for the diagnosis of dementias at an early stage of the disease when it remains a challenge,” said Bruno Dubois, director of the Memory and Alzheimer’s Disease Institute at Pitié Salpêtrière Hospital in Paris, in a news release. “The automatic quantification of markers such as brain atrophy, white matter hyperintensities and more, provides highly valuable help to support a timely diagnosis and an efficient monitoring of disease progression.”
“FDA clearance is a major milestone to expand the commercialization of the software within the U.S.,” added Qynapse CEO Olivier Courrèges. “Qynapse will accelerate collaboration with experts and healthcare providers in the U.S. to pursue its journey for better patient care in neurology.”
QyScore gained the CE Mark in Europe in 2017.